Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | SYNRIBO | — | 2014-02-10 | fda.gov ↗ |
| Approved | US (FDA) | SYNRIBO | — | 2012-10-26 | fda.gov ↗ |
Trials 58 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT07437170 Background | Jan 2024 → Dec 2027 expected | childhood acute myeloid leukemia | The Children's Hospital of Zhejiang University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05029141 Background | Sep 2021 → Dec 2026 expected | acute myeloid leukemia | The First Affiliated Hospital of Soochow University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04126681 Comparator | Oct 2019 → Aug 2024 | chronic myeloid leukemia | Ascentage Pharma Group Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05726110 Background | Jan 2023 → Dec 2024 overdue | acute myeloid leukemia | Shanxi Bethune Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04722952 Background | May 2021 → Jan 2023 | acute myeloid leukemia | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 3 | NCT04716114 Comparator | Mar 2021 → Dec 2025 | acute myeloid leukemia | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT03978364 Comparator | Jun 2019 → Jun 2022 | acute myeloid leukemia | Shandong Provincial Hospital | Unknown | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Approves Teva’s SYNRIBO® (Omacetaxine Mepesuccinate) for Injection for Home Administration tevapharm.com ↗ |
| 2014-02-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Full FDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗ |
| 2012-10-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Homoharringtonine | “A Single-arm, Single-center Clinical Trial Evaluating the Efficacy and Safety of a Regimen Combining Chidamide With Venetoclax, Azacitidine, and Homoharringtonine in the...” NCT07643636 ↗53“A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed/Refractory AML” NCT04501120 ↗ “An Randomized Controlled Study of Azacitidine Combined With Homoharringtonine Compared With Azacitidine for Patients With Int/High -Risk MDS and AML-MRC” NCT03978364 ↗ “Homoharringtonine (HHT) is an alkaloid and has been used in Chinese patients with acute and chronic myeloid leukemia for more than 30 years.” NCT04824924 ↗ “Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax/Azacitidine Pretreated AML Patients” NCT07505160 ↗ “cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion” NCT01417767 ↗ “Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells” NCT04424147 ↗ “Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7.” NCT06810791 ↗ “Homoharringtonine : 1mg/m2 per day by intravenous infusion from Day 1 to Day 7.” NCT07517510 ↗ “Homoharringtonine (HHT) is widely used for the treatment of myeloid leukemia.” NCT06328179 ↗ “Homoharringtonine injection (HHT) 2-3mg d1 to d14 was intravenously injected.” NCT05584761 ↗ “Homoharringtonine(HHT) 2mg/(m2.d) by IV on days 1-6 of every cycle” NCT04722952 ↗ “Venetoclax, Azacitidine, and Homoharringtonine (VAH) Combination” NCT07091006 ↗ “homoharringtonine, 1mg/m2 intravenously every day on days 3-16” NCT05029141 ↗ “homoharringtonine (HHT), cytarabine and aclarubicin (HAA)” NCT04716114 ↗ “Homoharringtonine:1mg/d, d4\~10, intravenous infusion” NCT06394011 ↗ “Homoharringtonine:1mg/d,d3\~16,intravenous infusion” NCT04087967 ↗ “Homoharringtonine 1 mg/m² IV daily on Days 1-5” NCT07172204 ↗ “Homoharringtonine(HHT) 1mg/(m2.d) for 14 days” NCT03873311 ↗ “daunorubicin,cytarabine,homoharringtonine” NCT04415008 ↗ “Homoharringtonine: 2mg/㎡/d, days 1-7” NCT06529250 ↗ “Homoharringtonine 1mg/m2 iv qd d1-14” NCT06470841 ↗ “Homoharringtonine (HHT) 2mg/m²/d” NCT07437170 ↗ “homoharringtonine 2mg IV d10-14” NCT03453255 ↗ “Homoharringtonine :1mg/d,d3” NCT04446130 ↗ “Homoharringtonine” NCT06529250 ↗ |
| Known as | HHT | “In luminal cells, EIF1A knockdown and the translation inhibitor homoharringtonine (HHT) both suppress HIF-1α translation and tumor growth, while promoting infiltration of...” PMID 41707646 ↗ Feb 202615“Homoharringtonine (HHT), a plant alkaloid with antitumor properties originally identified nearly 40 years ago, has a unique mechanism of action by preventing the initial...” NCT05513131 ↗ “Homoharringtonine (HHT) is currently the only small-molecule translation elongation inhibitor approved by the U.S. Food and Drug Administration (FDA).” NCT07516704 ↗ “Our preliminary research confirmed that homoharringtonine (HHT) significantly enhances the anti-leukemia effect of Ven/AZA via inhibition of MCL-1.” NCT07517510 ↗ “Homoharringtonine (HHT) is an alkaloid and has been used in Chinese patients with acute and chronic myeloid leukemia for more than 30 years.” NCT04824924 ↗ “The induction therapy is a combination of Venetoclax(Ven), Homoharringtonine(HHT) , Cytarabine and G-CSF.” NCT06742463 ↗ “Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells” NCT04424147 ↗ “Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7.” NCT06810791 ↗ “Homoharringtonine injection (HHT) 2-3mg d1 to d14 was intravenously injected.” NCT05584761 ↗ “Homoharringtonine (HHT) is widely used for the treatment of myeloid leukemia.” NCT06328179 ↗ “randomized doses of homoharringtonine (HHT) during early intensification” NCT06855810 ↗ “Homoharringtonine(HHT) 2mg/(m2.d) by IV on days 1-6 of every cycle” NCT04722952 ↗ “Homoharringtonine (HHT): 1 mg/m² intravenously on Days 1-7.” NCT07469046 ↗ “Homoharringtonine(HHT) 1mg/(m2.d) for 14 days” NCT03873311 ↗ “Homoharringtonine (HHT) 2mg/m²/d” NCT07437170 ↗ “homoharringtonine (HHT)” NCT04716114 ↗ |
| Known as | HHT, Omacetaxine mepesuccinate | “HHT, Omacetaxine mepesuccinate” NCT04248595 ↗ |
| Known as | omacetaxine | “Omacetaxine mepesuccinate (omacetaxine) is a first-in-class cephalotaxine” PMID 23468307 ↗ Mar 20131“Participants are administered homoharringtonine (omacetaxine)” NCT00114959 ↗ |
| Known as | omacetaxine mepesuccinate | “homoharringtonine (omacetaxine mepesuccinate)” PMID 35274287 ↗ Mar 2022 |
| Action | Inhibit | “As a protein synthesis inhibitor” NCT04248595 ↗ |
| Modality | Small molecule | “The homoharringtonie (HHT) is a plant cytotoxic alkaloid derived from the trees of the genus Cephalotaxus.” NCT04248595 ↗ |
| Route | Intravenous | “Given IV” NCT00003694 ↗ |
| Target | MCL1 | “through reduction of MCL1 and BCL-XL” PMID 40979071 ↗ Jul 2025 |